UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032337 |
|---|---|
| Receipt number | R000036786 |
| Scientific Title | The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room |
| Date of disclosure of the study information | 2018/04/29 |
| Last modified on | 2018/04/20 19:39:07 |
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Basic information
Public title
The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Acronym
The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Scientific Title
The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Scientific Title:Acronym
The effect of simulation education for the corresponding nurse at the time of massive bleeding in the operating room
Region
| Japan |
Condition
Condition
Mass bleeding
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of simulation education on nurse's correspondence during mass bleeding in the operating room.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perform OSCE simulation for both groups and evaluate.
For evaluation, comprehension level is evaluated by behavioral evaluation by checklist and comparison of knowledge tests before and after.
Key secondary outcomes
We will conduct a questionnaire and comprehension degree survey two weeks after the simulation and confirm the validity of the implementation time by seeing the change in understanding level over time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention period is half day in both groups
Interventions/Control_2
The number of interventions was 5 in both groups
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
It is targeted to those who were adopted in our hospital operating room in FY 2017 and who agreed among nurses who passed one year after entering the hospital
Key exclusion criteria
It does not include experienced nurse at the time of entering our hospital
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ritsuko Murai |
Organization
Nagoya University Hospital
Division name
Nursing department
Zip code
Address
65 Tsurumai-cho, Showa-ku,Nagoya city
TEL
052-741-2111
ritsu819@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Kitano |
Organization
Nagoya University Hospital
Division name
Nursing department
Zip code
Address
65 Tsurumai-cho, Showa-ku,Nagoya city
TEL
052-741-2111
Homepage URL
sarupo-piyopiyo@umin.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2018 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036786
